Benzinga | Oct 15, 2021 05:02PM EDT

Avadel Pharmaceuticals Announces Ongoing FDA Review Of NDA For FT218 For Patients With Narcolepsy

Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) notified the company that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October. The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.



"We have addressed all questions received to date and remain confident that the package we have submitted satisfies all of the FDA's requests. We have not been informed of any deficiencies in our application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218," said Greg Divis, Chief Executive Officer of Avadel. "Once-at-bedtime FT218 has the potential to truly impact the way people with narcolepsy are able to live their lives and we are dedicated to making this important therapy available to patients as quickly as possible."

In February 2021, the FDA accepted Avadel's NDA for FT218 and assigned a target action date of October 15, 2021. The NDA submission is supported by positive data from the pivotal Phase 3 REST-ON study, which was completed under a Special Protocol Assessment (SPA) agreement with the FDA.